Novavax : Complete PREVENT-19 Phase 3 Clinical Trial Results Manuscript for COVID-19 Vaccine Posted to medRxiv

Full results from the PREVENT-19 pivotal Phase 3 trial of Novavax' COVID-19 vaccine candidate have been posted to the medRxiv preprint server. The trial achieved its primary endpoint in which NVX-CoV2373, Novavax' recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall.

PREVENT-19 was a randomized, observer-blinded, placebo-controlled trial conducted in nearly 30,000 adults in the United States and Mexico. Participants were 18 years of age and older and randomized in a 2:1 ratio to receive two 5?g doses of NVX-CoV2373 with 50?g Matrix-MTM adjuvant, or placebo, 21 days apart. Sites were selected to prioritize racial and ethnic diversity, as well as participants at high risk of acquisition or complications of COVID-19. The trial also included a blinded crossover where those originally randomized to placebo received active vaccine and vice versa, ensuring all participants received NVX-CoV2373 without compromising Food and Drug Administration (FDA)-required safety follow-up.

The trial achieved its primary endpoint of efficacy in preventing polymerase chain reaction (PCR)-confirmed, symptomatic mild, moderate or severe COVID-19 with onset at least 7 days after the second dose. Solicited adverse events were predominantly mild-to-moderate and transient, were more frequent in the vaccine recipients and increased after the second dose. Severe reactions were infrequent and there were no safety concerns related to vaccination.

The manuscript, 'Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico,' has also been submitted for peer review. Initial findings from this study were shared on June 14.

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